Nagaland University Researchers Identify Sinapic Acid as Promising Diabetic Wound Treatment

Researchers at Nagaland University have identified a plant compound called Sinapic acid that can accelerate diabetic wound healing by activating the SIRT1 pathway. The study, published in Nature Scientific Reports, found that the compound works by promoting tissue repair, reducing inflammation, and promoting new blood vessel formation. This discovery has the potential to lead to safe, natural, and effective treatments for diabetic wound management.

Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, has announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial" in the International Wound Journal Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1]. The study demonstrated the safety and efficacy of PDA-002, a placenta-derived cell therapy, in treating diabetic foot ulcers (DFU) complicated by peripheral artery disease (PAD).

Approximately two million individuals in the United States are affected each year by DFU, with nearly half of these patients also having PAD. The estimated annual economic burden of treating DFU alone exceeds $9 billion in the United States Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1]. The presence of PAD significantly compromises lower-extremity perfusion, leading to chronic tissue ischemia, impaired angiogenesis, and delayed wound repair. Despite five FDA-approved DFU therapies, none are currently approved for DFU complicated by PAD, underscoring the need for novel regenerative approaches Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1].

The study included 159 adult patients with chronic diabetic foot ulcers (both with and without PAD) and was conducted across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002, a placenta-derived cell therapy developed by Celularity, at one of three dosage levels (3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells), or a placebo. The primary efficacy endpoint was the number of patients who achieved complete wound closure within three months with healing that remained intact for at least four additional weeks.

In patients with PAD, the highest rates of wound closure were observed with the lowest PDA-002 dose (3 × 10⁶ cells), where 38.5% of ulcers completely healed versus 22.6% in the placebo group. The data also showed faster and more sustained healing in treated patients along with fewer cases of new gangrene and foot infections compared to those who received a placebo. Across all groups, PDA-002 was well tolerated, with no serious side effects linked to the treatment. This favorable safety profile remained consistent through two years of follow-up Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1].

The study's findings highlight the regenerative and angiogenic potential of PDA-002 in promoting durable ulcer closure in patients with DFUs complicated by PAD, using only two doses and no retreatment. Celularity's Chairman and CEO, Robert J. Hariri, M.D., Ph.D., commented on the significance of these results, stating that they position the company for a confirmatory Phase 3 trial aimed at delivering the first FDA-approved targeted therapy in regenerative wound care for DFU/PAD patients Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1].

Celularity is also actively assessing opportunities to apply these findings in jurisdictions such as Florida, where PDA-002 qualifies as a stem cell therapy under a new law authorizing use by Florida physicians in wound care, orthopedics, and pain management Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1]. This development is particularly significant given that diabetes afflicts an estimated 2.1 million Floridians, with the percentage of adult Floridians diagnosed with diabetes growing by almost half since 2002 and now above the national average (12.2% versus 11.6%) Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease^[1].